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Hepcludex

Hepcludex (bulevirtide) is the first approved therapy with an indication specifically for chronic hepatitis D virus (HDV) infection, a severe form of viral hepatitis seen in patients co-infected with hepatitis B virus (HBV). The drug prevents the virus from entering liver cells, which helps prevent further infection and damage to the liver.

Hepcludex is a new treatment for the treatment of hepatitis D and an important unmet medical need for patients at risk of cirrhosis, liver failure and liver cancer. Its selective antiviral activity provides a promising option for slowing disease progression and improving long-term liver health outcomes.

The information outlined in the molecule details section below would help you plan aBLA development early to enable a streamlined and competitive biosimilar strategy.

Molecule Details :

  • Molecule Name :

    Bulevirtide-Gmod
  • Innovator :

    GILEAD SCIENCES, INC.
  • Approval Date :

    22-May-26
  • Data Exclusivity Expiry :

    22-May-30
  • Market Exclusivity Expiry :

    22-May-38
  • Dosage Form :

    Powder,for Solution Injection
  • Strength :

    8.5MG
  • Therapeutic Category :

    Antiviral
  • Revenue ($M) :

    NA

Year-wise Projected Sales ($M) :

  • 2025 :

    NA
  • 2026 :

    NA
  • 2027 :

    NA
  • 2028 :

    NA
  • 2029 :

    NA
  • 2030 :

    NA
  • 2031 :

    NA
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